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Health Canada has notified Martek Biosciences Corporation (Martek) that it has no objection to the sale of the products DHASCO« and ARASCO« for use as sources of docosahexaenoic acid (DHA) and arachidonic acid (ARA), respectively, in infant formulas (human milk substitutes). The Department conducted a comprehensive assessment of these oils, including toxicology, chemistry, microbiology, and nutrition.

Background:

The following provides a summary of the Martek notification to Health Canada and contains no confidential business information.

1. Introduction

DHASCO« refers to a mixture of an oil extracted from the unicellular alga Crypthecodinium cohnii and high oleic sunflower oil (HOSO). The resulting mixed oil contains 40-45% of product weight as DHA. ARASCO« refers to a mixture of an oil extracted from the unicellular fungus Mortierella alpina and HOSO, and contains 38-44% ARA by weight. DHA and ARA are long-chain polyunsaturated fatty acids (LCPUFAs) that are naturally present in a variety of human foods, including breast milk. At present, infant formulas in Canada do not contain any DHA or ARA.

2. Development and Production of DHASCO« and ARASCO«

Methods for production of DHASCO« and ARASCO« from C. cohnii and M. alpina, respectively, have been published. Specific, proprietary production strains of C. cohnii and M. alpina and food grade materials are used in the production process. Oils from the biomasses are extracted and processed using procedures that are well established in the edible oil industry. The DHA and ARA contents of DHASCO« and ARASCO«, respectively, are standardized using HOSO. The oils undergo analytical and quality assurance testing and must meet defined specifications prior to release.

3. Product Information

DHASCO« and ARASCO« contain DHA and ARA, respectively, as triglycerides, with no detectable levels of eicosapentaenoic acid (EPA) or other LCPUFAs. Levels of EPA are consistently low in breast milk, and the addition of fish oils containing EPA to infant formulas has been associated with a decreased rate of growth. The major sterols present in DHASCO« and ARASCO« are consistent with those found in other human foods, such as fish and shellfish.

4. Dietary Exposure

DHASCO« and ARASCO« will be used as sources of DHA and ARA solely in infant formulas. Health Canada has not set out a specific level of use of DHASCO« and ARASCO« oils in infant formulas. Appropriate levels of addition will be established based on information provided by infant formula manufacturers in premarket notifications for products containing these oils.

5. Nutritional Quality

Evidence from a number of scientific studies demonstrates that the triglycerides containing DHA and ARA from DHASCO« and ARASCO« are absorbed by healthy infants in the same manner as other dietary triglycerides. Blood EPA levels also appear to be unaffected by consumption of formulas supplemented with DHASCO« and ARASCO« and there is no evident, significant retroconversion of DHA to EPA. Clinical studies show that infant formulas containing DHASCO« and ARASCO« support normal growth and development in healthy term and pre-term infants. Furthermore, a number of government and international scientific bodies have made recommendations with respect to the DHA and ARA contents of pre-term and term infant formulas. The Life Sciences Research Office, Federation of American Societies for Experimental Biology (2002), stated that infant formula for pre-term infants should contain no more than 0.35% and 0.6% of total fatty acids as DHA and ARA, respectively, and that, when these fatty acids are added, the ratio of ARA to DHA should be between 1.5 and 2.0. The Food and Nutrition Board, Institute of Medicine, National Academy of Sciences, in their report Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids (2002), established an adequate intake of 0.5 g/day of n-3 polyunsaturated fatty acids for infants 0 to 6 months of age, which includes 0.04 g/day of DHA. No level of intake of DHA was specified for infants older than 6 months.

6. Safety

The strains of C. cohnii and M. alpina used in the production of DHASCO« and ARASCO« have not been derived through rDNA techniques. No toxicological, microbiological, or chemical concerns are associated with the supplementation of infant formulas with DHASCO« and ARASCO«.

Conclusion:

Health Canada's review of the information presented in support of the addition of DHASCO« and ARASCO« to infant formula does not raise concerns related to toxicological, microbiological, chemical, or nutritional safety. Health Canada is of the opinion that DHASCO« and ARASCO« are acceptable sources of DHA and ARA for infant formulas.

Health Canada's opinion pertains only to the use of DHASCO« and ARASCO« as sources of DHA and ARA in infant formula. No level of addition of DHASCO« and ARASCO« in formulas is specified. Pursuant to Division 25 of the Food and Drug Regulations, any manufacturer of infant formulas containing DHASCO« and/or ARASCO« would be required to submit to Health Canada evidence that the formulas are safe and nutritionally adequate to support acceptable growth and development in infants as part of the premarket notification for the formulas. Furthermore, any specific use of DHASCO« and ARASCO« in foods other than infant formulas would require a separate novel food notification pursuant to Division 28 of the Regulations.